The Manufacturing Engineer II is responsible for optimizing production processes, resolving technical challenges, and improving operational efficiency in the manufacturing of medical devices. This role requires strong problem-solving capabilities, accountability for results, and a collaborative One ATL mindset to support business, quality, and operational objectives.
Key ResponsibilitiesDesign, develop, and implement manufacturing process improvements to increase efficiency, reduce costs, and enhance product quality.
Conduct root cause analyses and implement sustainable solutions for production issues, quality defects, and nonconformances.
Demonstrate accountability for assigned KPIs, including monitoring performance, identifying gaps, and driving corrective actions to achieve established targets.
Maintain clear ownership of applicable SOPs, ensuring procedures remain accurate, current, compliant, and effectively implemented within the operation.
Collaborate with cross-functional teams, including Design Engineering, Quality, Operations, and Supply Chain, to ensure the manufacturability of new products and design changes.
Develop and maintain technical documentation, including work instructions, process specifications, standard operating procedures, control plans, and validation documentation.
Participate in the selection, qualification, installation, and validation of manufacturing equipment, tooling, and processes.
Train and support production personnel on new processes, equipment, procedures, and technical requirements.
Ensure compliance with applicable industry regulations, including ISO 13485 and FDA requirements, as well as internal quality standards and procedures.
Lead or actively participate in continuous improvement initiatives using Lean Manufacturing, Six Sigma, and structured problem-solving methodologies.
Promote teamwork, knowledge sharing, and cross-functional collaboration to deliver results aligned with the One ATL mindset.
Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Electronic Engineering, or a related field.
A minimum of three to five years of progressive experience in manufacturing engineering, preferably within the medical device industry.
Strong knowledge of manufacturing principles, assembly processes, process optimization, and technical problem-solving methodologies.
Experience with Design of Experiments (DOE), Statistical Process Control (SPC), root cause analysis, and continuous improvement methodologies such as Lean Manufacturing and Six Sigma.
Proficiency in CAD software, such as SolidWorks or AutoCAD, and data analysis tools.
Ability to interpret engineering drawings, technical specifications, process requirements, and applicable engineering standards.
Strong ownership and accountability for KPIs, SOP compliance, project deliverables, and operational results.
Excellent verbal and written communication skills in both Spanish and English at an intermediate to advanced level.
Proven ability to work independently while contributing effectively within multidisciplinary teams.
Strong teamwork, organizational, and project management skills, with the ability to manage multiple priorities simultaneously.
Demonstrated ability to approach challenges with a proactive, analytical, and solution-oriented mindset.
Commitment to collaboration, accountability, operational excellence, and the One ATL mindset.
Skills Required
- Bachelor's degree in Mechanical, Industrial, Electronic Engineering, or related field
- 3-5 years progressive manufacturing engineering experience
- Experience in the medical device industry
- Experience with Design of Experiments (DOE), Statistical Process Control (SPC), and root cause analysis
- Knowledge and application of Lean Manufacturing and Six Sigma methodologies
- Proficiency with CAD software (SolidWorks or AutoCAD) and data analysis tools
- Ability to interpret engineering drawings, technical specifications, and process requirements
- Experience developing work instructions, process specifications, SOPs, control plans, and validation documentation
- Familiarity with ISO 13485 and FDA regulatory requirements
- Intermediate to advanced verbal and written communication skills in Spanish and English
- Strong problem-solving, project management, teamwork, and ability to work independently
What We Do
ATL Technology is a full-service, vertically integrated engineering and manufacturing partner to the world's leading medical device OEMs. Founded in 1993 and based in Springville, Utah, the company specializes in the design and manufacture of advanced medical device solutions, including custom interconnect solutions and components for minimally invasive procedures and patient monitoring systems.
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